Multiple SclerosisPhase 1/2PHOMSNCT05168384

Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis

A Phase 1/2 study testing Extracorporeal Photopheresis in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
What is being tested?: Extracorporeal Photopheresis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Arab Emirates
Study dates: 26 Mar 2022to 27 Apr 2026
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Demonstrate Expanded Disability Status Scale (EDSS) scores between 3 to 6.5 at screening.
Documented EDSS progression in the 2 years prior to screening of 1 point or greater for patients with an EDSS score less than 6 at baseline, and greater than or equal to 0.5 for patients with an EDSS score greater than or equal to 6.0 at baseline *.
If documented EDSS scores are not available, a written summary of the clinical evidence of disability progression over the last 2 years, and retrospective assessment of EDSS score from data in the medical records, must be submitted for review by the principal investigators.
Documented initial onset characterized by a relapsing-remitting course as described in the Diagnostic Criteria.
Age ≥ 18 ≤ 75 years.
Weight > 40 kg.

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Hematocrit ≥ 28 % (with or without transfusion support).
Platelet count > 100,000 per μL (with or without transfusion support).
Willingness to use at least 1 reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.
Willingness to participate in all PHOMS Study tests, visits, and procedures (including the ECP), as outlined in the informed consent.
Patients must have adequate peripheral venous access to initiate ECP therapy, and central line insertion shall be required.
The patient agrees to participate in the trial and signs the PHOMS Study informed consent form.

Who cannot join

Absolute medical contraindication to receive ECP.
Laboratory evidence of any of the following:
White blood cells (WBC) < 2,000 cells per uL.
Serum transaminase levels > x 2 UNL.
Creatinine Clearance < 60 mL/min.
Concurrent diagnosis of a neurological condition that would interfere with the assessment of MS, or an autoimmune disease or inflammatory condition that is chronically treated with immunosuppressive agents.

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Evidence of known infection with human immunodeficiency virus (HIV) or active (not including latent) Hepatitis B.
Uncontrolled infection requiring treatment at study entry.
Hypersensitivity or allergy to psoralen (methoxalen).
Hypersensitivity or allergy to both heparin and citrate products (If hypersensitive or allergic to only one of these products, exclusion does not apply).
Inability to tolerate fluid changes associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
Presence of aphakia or photosensitive disease (systemic lupus erythematosus, porphyrias, etc.).
Women who are pregnant and/or lactating.
Use of any investigational drug/treatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmodynamic effect has returned to baseline, whichever is longer.
Inability to undergo MRI scans.
Contraindication to gadolinium due to past allergic, hypersensitive, or adverse reaction or impaired renal function. Patients receiving a steroid prep prior to gadolinium administration due to history of hypersensitivity or allergy to other agents or due to prior mild reaction to gadolinium will not be excluded from the study.
Poor venous access.
Previous history of skin cancer, leukemia / lymphoma / myeloma, or bone marrow transplant.
Patients taking Coumadin who are unable to switch from oral anticoagulants to enoxaparin.
Heparin-induced thrombocytopenia.
Poor cardiac function.
Severe hypotension.
Any other disease or condition which, in the opinion of the investigator, could interfere with participation according to the PHOMS Study Protocol, or with the ability of the patients to cooperate and comply with study procedures.
Inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

Abu Dhabi Stem Cells Center
Abu Dhabi, Abu Dhabi Emirate, 4600

Other trials in United Arab Emirates

About this study

Official title: Randomized, Controlled, Open-label Study Evaluating the Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis

PHOMS Study is a randomized, controlled, open-label, prospective, and multicentric clinical trial involving outpatients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Relapsing-Remitting Multiple Sclerosis (RRMS). The primary objective is the safety profile assessment of the investigational intervention (Extracorporeal Photopheresis -ECP) and its preliminary efficacy evaluation, while the secondary objective is the assessment of the immune response profile in MS patients.

Read the detailed description

PHOMS patients will be randomly allocated (2:1) in a parallel assignment involving two groups of participants: Group A (Experimental group, n = 30): ECP plus Multiple Sclerosis (MS) standard of care, or Group B (Control group, n = 15) receiving MS standard of care alone. The PHOMS Study standard of care is defined by Disease-modifying Therapy (DMT) recommended by the American Academy of Neurology (AAN). The Study will be conducted within Abu Dhabi Stem Cells Center (ADSCC) and Yas Clinic Khalifa City (YCKC) Hospital, including patient assessment and inclusion, randomization, ECP procedures (Group A), and follow-up consultations, according to the approved Protocol and Good Clinical Practices (GCPs) principles. The primary objective is the safety profile assessment of the investigational intervention (ECP), to be assessed by procedure tolerability, the incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0), and the World Health Organization - Uppsala Monitoring Center (WHO-UMC) causality assessment system. The ECP preliminary efficacy assessment, as another primary objective, will be assessed by the proportion of subjects with no evidence of disease progression at 1 year; while the secondary objective is the assessment of the immune response profile in MS patients. All subjects will undergo longitudinal Expanded Disability Status Scale (EDSS), 25-foot walk ambulation test, 9-hole peg test, and 36-Item Short Form Survey (SF-36) testing at baseline and every 3 months through 1 year. Blood will be collected for immunological testing at baseline, months 3, 6, 9, and 12; and subjects will also undergo neuroimaging with brain Magnetic Resonance Imaging (MRI) at baseline, and months 6 and 12 following initiation of treatment, while Chest X-Ray, electrocardiogram (ECG), and echocardiogram can be required at the discretion of the Investigator. The trial is approved by the institutional Research Ethics Committees (RECs), and written informed consent will be obtained from all patients. PHOMS Study will be conducted following the principles of the Declaration of Helsinki and the International Conference on Harmonization (ICH) GCP Guidelines. The authors are responsible for designing the trial and for compiling and analyzing the data.

Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
Being tested: Extracorporeal Photopheresis, MS standard of care
Keywords: Extracorporeal Photopheresis, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Medical subject headings: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extracorporeal PhotopheresisCombination product
Also called Extracorporeal Photoimmunotherapy, Photochemotherapy
ECP procedures will be performed using a Therakos Cellex integrated, closed photopheresis system (Therakos, Inc., a Mallinckrodt Pharmaceuticals Company).
ECP will administered according to the following schedule (Group A):
Weeks 1-8: Twice per week (16 sessions). Weeks 9-16: Once per week (8 sessions). Weeks 17-24: Once every 2 weeks (4 sessions). Total: 28 sessions (within 24 weeks).
MS standard of careCombination product
Also called Disease-modifying Therapies
Disease-modifying Therapy -DMT, recommended by the American Academy of Neurology -AAN

Study groups in NCT05168384
Study group	Role	What they receive
Group A (ECP + SoC Group)	Experimental	Extracorporeal photopheresis (ECP) plus Multiple Sclerosis (MS) standard of care Receives: Combination Product: Extracorporeal Photopheresis; Combination Product: MS standard of care
Group B (SoC Group)	Active comparator	MS standard of care alone (SoC, defined by Disease-modifying Therapy -DMT, recommended by the American Academy of Neurology -AAN Receives: Combination Product: MS standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability to ECP procedures (Group A patients)
Proportion of patients tolerating the ECP procedures reaching the cycles' goal.
Measured: Weeks 0-24
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Proportion of patients referring TEAEs, AESIs, and SAEs assessed by CTCAE v5.0.
Measured: Weeks 0-52
Tolerability to TEAEs, AESIs, and SAEs
Proportion of patients tolerating TEAEs, AESIs, and SAEs, and finalizing the Study
Measured: Weeks 0-52
Clinical improvement (25-foot walk)
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the timed 25-foot walk
Measured: Baseline, months 3, 6, 9, and 12
Clinical improvement (9-hole peg test)
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the 9-hole peg test
Measured: Baseline, months 3, 6, 9, and 12
Clinical improvement (36-Item Short Form Survey)
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the 36-Item Short Form Survey (SF-36)
Measured: Baseline, months 3, 6, 9, and 12
Clinical improvement (EDSS baseline low score)
Proportion of patients with clinical improvement from baseline in 1 point or greater increase in EDSS score (in subjects with baseline EDSS scores between 3 and 5.5)
Measured: Baseline, months 3, 6, 9, and 12
Clinical improvement (EDSS baseline high score)
Proportion of patients with clinical improvement from baseline in 0.5 point or greater increase in EDSS score (in subjects with baseline EDSS scores ≥ than 6)
Measured: Baseline, months 3, 6, 9, and 12
Occurrence of clinical relapse at any point in the study
Proportion of patients demonstrating new or recurrent neurological symptoms consistent with MS, symptoms last 24 to 48 hours, or development of new MS symptoms over days to weeks
Measured: Weeks 0-52

Secondary outcomes (2)

Immune response profile (cellular)
Analysis of the biomarkers CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, for identification of immune cells and subsets analysis
Measured: Baseline, months 3, 6, 9, and 12
Immune response profile (humoral)
IgG, IgA, IgM levels will be assessed for characterization of the humoral response profile
Measured: Baseline, months 3, 6, 9, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202227 Apr 2026

First posted23 Dec 2021
Study start26 Mar 2022
Primary completion1 Sep 2025
Study completion27 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05168384
Sponsor's protocol ID: CT.005.2.0.PHOMS
Other IDs: DOH/CVDC/2022/155
Acronym: PHOMS
Status last verified: May 2026
First submitted: 25 Nov 2021
Last updated: 7 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Castillo-Aleman YM, Villegas-Valverde CA, Ventura-Carmenate Y, Al-Kaabi FM, Lumame S, Castelo C, Mir R, Brylev L, Atieh M, Haider MT, Bencomo-Hernandez AA. Mononuclear cell recruitment during extracorporeal photopheresis: Partial results of a phase 1/2 randomized clinical trial in multiple sclerosis. Transfus Apher Sci. 2025 Apr;64(2):104095. doi: 10.1016/j.transci.2025.104095. Epub 2025 Feb 9.
PubMed 39947046
Castillo-Aleman YM, Lumame S, Castelo C, Mir R, Ventura-Carmenate Y, Al-Kaabi FM. Recurrent clumping in the extracorporeal photopheresis circuit using acid citrate dextrose solution A. J Clin Apher. 2024 Jun;39(3):e22117. doi: 10.1002/jca.22117. No abstract available.
PubMed 38661254

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Open-label Study Evaluating the Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis
ClinicalTrials.gov ID: NCT05168384
Acronym / sponsor ID: PHOMS / CT.005.2.0.PHOMS
Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive
Keywords: Extracorporeal Photopheresis, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Abu Dhabi Stem Cells CenterOther government
Study start: 26 Mar 2022 (actual)
Primary completion: 1 Sep 2025 (actual)
Study completion: 27 Apr 2026 (actual)
First posted: 23 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A (ECP + SoC Group)	Experimental	Combination Product: Extracorporeal Photopheresis, Combination Product: MS standard of careExtracorporeal photopheresis (ECP) plus Multiple Sclerosis (MS) standard of care
Group B (SoC Group)	Active comparator	Combination Product: MS standard of careMS standard of care alone (SoC, defined by Disease-modifying Therapy -DMT, recommended by the American Academy of Neurology -AAN

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Demonstrate Expanded Disability Status Scale (EDSS) scores between 3 to 6.5 at screening.
Documented EDSS progression in the 2 years prior to screening of 1 point or greater for patients with an EDSS score less than 6 at baseline, and greater than or equal to 0.5 for patients with an EDSS score greater than or equal to 6.0 at baseline *.
Documented initial onset characterized by a relapsing-remitting course as described in the Diagnostic Criteria.
Age ≥ 18 ≤ 75 years.
Weight > 40 kg.

Key exclusion criteria (24 listed)

Absolute medical contraindication to receive ECP.
Laboratory evidence of any of the following:
Concurrent diagnosis of a neurological condition that would interfere with the assessment of MS, or an autoimmune disease or inflammatory condition that is chronically treated with immunosuppressive agents.
Evidence of known infection with human immunodeficiency virus (HIV) or active (not including latent) Hepatitis B.
Uncontrolled infection requiring treatment at study entry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extracorporeal PhotopheresisAlso: Extracorporeal Photoimmunotherapy, PhotochemotherapyECP procedures will be performed using a Therakos Cellex integrated, closed photopheresis system (Therakos, Inc., a Mallinckrodt Pharmaceuticals Company). ECP will administered according to the following schedule (Group A): Weeks 1-8: Twice per week (16 sessions). Weeks 9-16: Once per week (8 sessions). Weeks 17-24: Once every 2 weeks (4 sessions). Total: 28 sessions (within 24 weeks).	Combination product	Group A (ECP + SoC Group)
MS standard of careAlso: Disease-modifying TherapiesDisease-modifying Therapy -DMT, recommended by the American Academy of Neurology -AAN	Combination product	Group A (ECP + SoC Group), Group B (SoC Group)

Primary outcome

Tolerability to ECP procedures (Group A patients)
Time frame: Weeks 0-24
Proportion of patients tolerating the ECP procedures reaching the cycles' goal.
Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Time frame: Weeks 0-52
Proportion of patients referring TEAEs, AESIs, and SAEs assessed by CTCAE v5.0.
Tolerability to TEAEs, AESIs, and SAEs
Time frame: Weeks 0-52
Proportion of patients tolerating TEAEs, AESIs, and SAEs, and finalizing the Study
Clinical improvement (25-foot walk)
Time frame: Baseline, months 3, 6, 9, and 12
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the timed 25-foot walk
Clinical improvement (9-hole peg test)
Time frame: Baseline, months 3, 6, 9, and 12
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the 9-hole peg test
Clinical improvement (36-Item Short Form Survey)
Time frame: Baseline, months 3, 6, 9, and 12
Proportion of patients with clinical improvement from baseline in 20% or greater increase in the 36-Item Short Form Survey (SF-36)
Clinical improvement (EDSS baseline low score)
Time frame: Baseline, months 3, 6, 9, and 12
Proportion of patients with clinical improvement from baseline in 1 point or greater increase in EDSS score (in subjects with baseline EDSS scores between 3 and 5.5)
Clinical improvement (EDSS baseline high score)
Time frame: Baseline, months 3, 6, 9, and 12
Proportion of patients with clinical improvement from baseline in 0.5 point or greater increase in EDSS score (in subjects with baseline EDSS scores ≥ than 6)
Occurrence of clinical relapse at any point in the study
Time frame: Weeks 0-52
Proportion of patients demonstrating new or recurrent neurological symptoms consistent with MS, symptoms last 24 to 48 hours, or development of new MS symptoms over days to weeks

2 secondary outcomes

Immune response profile (cellular)
Time frame: Baseline, months 3, 6, 9, and 12
Immune response profile (humoral)
Time frame: Baseline, months 3, 6, 9, and 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Background: PubMed 39947046Castillo-Aleman YM, Villegas-Valverde CA, Ventura-Carmenate Y, Al-Kaabi FM, Lumame S, Castelo C, Mir R, Brylev L, Atieh M, Haider MT, Bencomo-Hernandez AA. Mononuclear cell recruitment during extracorporeal photopheresis: Partial results of a phase 1/2 randomized clinical trial in multiple sclerosis. Transfus Apher Sci. 2025 Apr;64(2):104095. doi: 10.1016/j.transci.2025.104095. Epub 2025 Feb 9.
Background: PubMed 38661254Castillo-Aleman YM, Lumame S, Castelo C, Mir R, Ventura-Carmenate Y, Al-Kaabi FM. Recurrent clumping in the extracorporeal photopheresis circuit using acid citrate dextrose solution A. J Clin Apher. 2024 Jun;39(3):e22117. doi: 10.1002/jca.22117. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yendry Ventura Carmenate, M.D. principal investigator

Abu Dhabi Stem Cells Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability to ECP procedures (Group A patients) (time frame: Weeks 0-24). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168384, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.